The Acute Burn Resuscitation Multicenter Prospective Observational Trial
| Status: | Recruiting |
|---|---|
| Conditions: | Other Indications, Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/28/2018 |
| Start Date: | February 24, 2017 |
| End Date: | August 30, 2020 |
| Contact: | Katrina Falwell, BSN |
| Email: | kafalwell@ucdavis.edu |
| Phone: | 916-453-2134 |
This is a prospective, non-interventional, observational study of consecutive burn patients
admitted to 20 selected burn centers in North America. Primarily, data collection will be
continuous "real-time" documentation of fluid infusion rates, vital signs and laboratory
values of patients receiving fluid resuscitation during the first 48 hours following burn
injury. All aspects of the resuscitation and all investigations performed will be according
to the participating center's regular protocol, as this is purely an observational and
non-interventional study. Further data collection on outcomes (organ function, ventilation
duration, length of stay, and survival) will be collected at 72h, 96 h, and at hospital
discharge.
admitted to 20 selected burn centers in North America. Primarily, data collection will be
continuous "real-time" documentation of fluid infusion rates, vital signs and laboratory
values of patients receiving fluid resuscitation during the first 48 hours following burn
injury. All aspects of the resuscitation and all investigations performed will be according
to the participating center's regular protocol, as this is purely an observational and
non-interventional study. Further data collection on outcomes (organ function, ventilation
duration, length of stay, and survival) will be collected at 72h, 96 h, and at hospital
discharge.
This is a prospective observational study with no intervention. Study sites have been
selected to include wide cross-representation of resuscitation practices using crystalloids
alone, crystalloid plus albumin, and among sites that use albumin, variable approaches to the
timing of albumin initiation.
Detailed data will be continuously collected in "real time" during fluid resuscitation over
the 1st 48 hours following a burn injury. Data collection during this phase will be done
prospectively, hour-by-hour, by the bedside nurse caring for the patient. Primarily this data
collection will involve recording of resuscitation fluid volumes, urinary output, vital signs
(heart rate and blood pressure), and use of vasopressors and inotropes. Outcome data (organ
function, need for mechanical ventilation, hospital length of stay, and survival) will be
collected at various time points during the subjects' acute care stay.
At completion of the study we intend to make the following comparisons:
1. Subjects that received crystalloids only compared to subjects that received crystalloids
plus albumin.
2. Subjects that had albumin started "early" (< 8 hours post burn), compared to subjects
that had albumin started "intermediate" (8-12 hours post burn), compared to subjects
that had albumin started "late" (>12 hours post burn).
3. Characteristics of resuscitation prior to the start of albumin ("pre-albumin") compared
to characteristics of resuscitation following initiation of albumin ("post albumin").
selected to include wide cross-representation of resuscitation practices using crystalloids
alone, crystalloid plus albumin, and among sites that use albumin, variable approaches to the
timing of albumin initiation.
Detailed data will be continuously collected in "real time" during fluid resuscitation over
the 1st 48 hours following a burn injury. Data collection during this phase will be done
prospectively, hour-by-hour, by the bedside nurse caring for the patient. Primarily this data
collection will involve recording of resuscitation fluid volumes, urinary output, vital signs
(heart rate and blood pressure), and use of vasopressors and inotropes. Outcome data (organ
function, need for mechanical ventilation, hospital length of stay, and survival) will be
collected at various time points during the subjects' acute care stay.
At completion of the study we intend to make the following comparisons:
1. Subjects that received crystalloids only compared to subjects that received crystalloids
plus albumin.
2. Subjects that had albumin started "early" (< 8 hours post burn), compared to subjects
that had albumin started "intermediate" (8-12 hours post burn), compared to subjects
that had albumin started "late" (>12 hours post burn).
3. Characteristics of resuscitation prior to the start of albumin ("pre-albumin") compared
to characteristics of resuscitation following initiation of albumin ("post albumin").
Inclusion Criteria:
- Age ≥ 18 years
- ≥ 20% TBSA burns
- Admitted to the burn center ≤ 12 post injury
Exclusion Criteria:
- Significant associated trauma
- High voltage (≥ 1000 volts) electrical burns
- Surgery anticipated within 48 hours from injury
- Fresh frozen plasma (FFP) anticipated to be given at any time ≤ 48 hours from injury
- Hypertonic saline (HTS) anticipated to be given at any time ≤ 48 hours from injury
- Hydroxyethyl starch (HES) anticipated to be given at any time ≤ 48 hours from injury
- High dose Vitamin C infusion is anticipated to be given at any time ≤ 48 hours from
injury
- Death occurs or comfort measures are instituted within ≤ 48 hours from injury
We found this trial at
1
site
2315 Stockton Boulevard
Sacramento, California 95817
Sacramento, California 95817
Principal Investigator: David Greenhalgh, MD
Phone: 916-453-2134
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